CytoDyn Inc (OTCQB:CYDY) announced Thursday that blood work shows that seven severe coronavirus (COVID-19) patients being treated with its drug leronlimab in New York City have shown a significant improvement after seven days in several important biologic markers.
In a statement, Bruce Patterson, the CEO of CytoDyn’s diagnostic partner and advisor IncellDX, said he is impressed with the results so far.
“The Day-7 results from these patients demonstrates even more dramatic immune restoration especially in the CD8 T-lymphocyte population, the major immune cell responsible for eliminating virally infected cells,” he added.
“In addition, there is a further dramatic reduction in the critical cytokine storm cytokines IL-6, TNF-alpha. Collectively, these results are correlating with patients’ recovery. Some patients have been removed from ventilators, including one patient who was taken off of a heart/lung bypass machine,” Patterson said.
He also noted that the “critically ill patients” are experiencing the benefit of “extubating within 7 days of treatment with leronlimab.”
CytoDyn also said a patient with “severe COVID-19” in a hospital in Southern California improved dramatically after being given leronlimab. The patient was in the ICU and had received an IL-6 blocking agent four days earlier without any benefit.
Concomitantly, the patient also received either an antiretroviral agent, or placebo as part of an unrelated clinical trial. With no clinical improvement over the ensuing four days, the patient then received leronlimab under the US Food and Drug Administration’s (FDA) emergency Investigational New Drug (IND) program.
“Within 24 hours of receiving an injection of leronlimab, the patient showed significant clinical improvement and was removed from external ventilation three days later,” said the company.
It noted that the outcome is consistent with those observed in severely ill coronavirus patients treated with leronlimab at the leading medical center in New York City.
Additionally, two patients at the same Southern California medical center with “moderate COVID-19,” were treated with leronlimab under an emergency IND and got better too.
“These patients were removed from external oxygen support one day following leronlimab treatment, and subsequently discharged from the hospital,” said CytoDyn. Based on the positive outcome, an additional four patients with moderate coronavirus have been given leronlimab and the results are pending.
Sharing data with the FDA
CytoDyn CEO Nader Pourhassan commented: “We are very pleased that leronlimab appears to facilitate an immunological restoration in these patients and we are sharing our data with the FDA in order to hopefully accelerate the access of our drug to many more patients in need."
“With more than 20 emergency INDs approved by the FDA, we are receiving an overwhelming number of emergency IND requests from all over the country,” he added.
The FDA recently gave the nod for CytoDyn to initiate a Phase 2b/3 clinical trial for severe and critically ill coronavirus patients for whom enrollment is now underway.
The trial is for 390 patients and will be double-blinded with a 2:1 drug to placebo ratio. Patients are expected to be given leronlimab for two weeks, and the primary endpoint of the study is the mortality rate after 28 days. There is a secondary endpoint mortality rate at 14 days. An interim analysis of the data will be conducted after the first 50 patients.
CytoDyn has also initiated enrollment in a Phase 2 randomized clinical trial for mild-to-moderate coronavirus patients in the US.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive